Liver damage

No definite association between liver injury and Orlistat (alli) has been established

You may be concerned about reports in the press concerning Orlistat (alli®) and a safety investigation by the Food & Drug Administration (FDA) in the US. On August 24 FDA reported on its website that they were in the process of an ongoing safety review regarding orlistat and reports of liver injury. This information was an update of an earlier communication. It is normal practice for the FDA and other regulatory agencies to review the safety profile of medicines regularly. Assessment by a regulatory agency does not mean that a risk with a particular medicine has been confirmed. The FDA is currently advising consumers using Orlistat (alli) to continue to use the product as directed.

As an Orlistat (alli) user, should I be concerned about the possible effect of Orlistat (alli) on my liver?

It is normal practice for the FDA and other regulatory agencies to review the safety profile of medicines regularly. The FDA is currently reviewing all available data regarding liver injury. This does not mean that a definite association between liver injury and Orlistat (alli) has been established. The FDA is currently advising consumers using Orlistat (alli) to continue to use the product as directed.

Orlistat (alli) is the weight loss medicine with the most safety information, based on clinical studies and real market experience.

Orlistat, the active ingredient in alli is the most-studied weight loss medicine, with safety established through over 100 clinical studies involving more than 30 thousand patients. In clinical studies patients treated with orlistat showed no higher incidence of liver-related adverse events than those receiving placebo (dummy treatment).¹

Orlistat, the active ingredient in alli, has been available globally for over 10 years and over thirty five million people have taken this medicine.

alli is continually monitored for safety

The safety of consumers is of utmost importance to GSK, as the manufacturers of Orlistat (alli). We continually monitor and evaluate reports of adverse effects associated with use of all of our products, including Orlistat (alli®).

GSK regularly communicates with independent regulatory bodies and provides them with comprehensive safety data on our products. Routine assessment from a regulatory agency does not mean that a risk has been confirmed or that Orlistat (alli®) causes any health problems.

References

  1. Roche Xenical NDA 20-766. Submitted November 1996. Approved April 1999.
  2. Anderson J. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60 mg, over-the-counter dosage. Expert Opinion on Pharmacotherapy. 2007; 8(11): 1733 – 1742
  3. Jacob S and Torgersen J. Orlistat treatment beneficial in both primary care and tertiary care settings. Obesity Reviews. 2005; 6(s1):166
  4. Kaplan LM. Leptin, obesity, and liver disease. Gastroenterology 1998; 115: 997-1001
  5. Scheen AJ and Luyckx FH. Obesity and liver disease. Best Practice & Research Clinical Endocrinology and Metabolism 2002; 16(4): 703-716



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